Telavancin

Summary

Telavancin (Vibativ) is a semisynthetic lipoglycopeptide antibiotic approved for the treatment of complicated skin and skin structure infections (cSSSI) and hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible Gram-positive organisms, including methicillin-resistant Staphylococcus aureus (MRSA).

Mechanism of Action

Telavancin is a bactericidal lipoglycopeptide that inhibits bacterial cell wall synthesis by binding to D-Ala-D-Ala terminus of peptidoglycan precursors (similar to vancomycin), and additionally disrupts bacterial membrane potential and permeability by anchoring its lipophilic side chain into the membrane, leading to depolarization and cell death.

Routes of Administration

Goals & Uses

• Treatment of ventilator-associated bacterial pneumonia (VABP)Antibacterial / Infection TreatmentHigh
• Treatment of MRSA infectionsAntimicrobialHigh
• Treatment of bacteremia due to Gram-positive organismsAntibacterial / Infection TreatmentModerate
• Treatment of complicated skin and skin structure infections (cSSSI)Antibacterial / Infection TreatmentHigh
• Treatment of hospital-acquired bacterial pneumonia (HABP)Antibacterial / Infection TreatmentHigh

Contraindications

• Use with QTc-prolonging agents in patients with known QT prolongationCardiacModerate
• PregnancyPopulationHighPotential fetal risk or insufficient safety data
• Hypersensitivity to telavancin or any componentAllergyHigh
• Severe renal impairment (CrCl <10 mL/min)RenalHigh

Adverse Effects

• Interference with coagulation tests (PT, INR, aPTT)LaboratoryCommon
• QTc prolongationCardiacUncommon
• Foamy urineRenal / UrinaryCommon
• Nausea and vomitingGastrointestinalCommon
• Nephrotoxicity (renal impairment)RenalCommon
• Infusion-related reactions (Red Man Syndrome)Infusion ReactionCommon

Drug Interactions

• Nephrotoxic agents (aminoglycosides, NSAIDs, amphotericin B)High
• WarfarinLow
• QTc-prolonging drugs (e.g., haloperidol, amiodarone, fluoroquinolones)Moderate
• Unfractionated HeparinLow

Population Constraints

• Patients with pre-existing renal impairmentOrgan FunctionRelative
• Pediatric patientsAgeRelative
• Women of childbearing potential without contraceptionReproductiveRelative
• Patients with known QT prolongation or congenital long QT syndromeCardiacRelative
• Pregnant womenReproductiveAbsolute

Regulatory Status

• European UnionApprovedApproved: Nosocomial pneumonia including ventilator-associated pneumonia caused by MRSA, Complicated skin and soft tissue infections (cSSTI) due to Gram-positive organismsEMA granted marketing authorization; known as Vibativ in the EU. Risk management program required due to renal and reproductive risks.
• United StatesApprovedApproved: Complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive organisms, Hospital-acquired bacterial pneumonia (HABP) caused by susceptible Gram-positive organisms including MRSA, Ventilator-associated bacterial pneumonia (VABP) caused by susceptible Gram-positive organisms including MRSAFDA approved September 2009 (cSSSI) and June 2013 (HABP/VABP). Black Box Warnings for nephrotoxicity and embryo-fetal toxicity. Available under NDA 022110.
• United KingdomApprovedApproved: Nosocomial pneumonia due to MRSA, Complicated skin and soft tissue infections due to susceptible Gram-positive organismsApproved by MHRA; prescribing guided by local susceptibility data and specialist advice. Pregnancy testing mandatory pre-treatment.

FDA approved in 2009 for cSSSI and in 2013 for HABP/VABP. Carries a Black Box Warning regarding nephrotoxicity, embryo-fetal toxicity, and requirement for pregnancy testing before use. Use caution in patients with renal impairment.

Evidence & Sources

No sources recorded yet.